Thousands of pollution incidents in England downgraded without site visit, data suggests

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Because the early safety results were strong, the Food and Drug Administration and an independent monitoring board approved moving forward with the next phase of the study.

"It is interesting that a lot of the things that we are addressing directly go to the points they raised in their report," Isaacman said Friday. "I can't say we actually collaborated on it because I generally think these were all pretty obvious observations."

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